Establish limits for fitness to drive with prolonged use of ICADTS class III medicatio

Phase 4

Completed

Conditions: depressieve stemmingsstoornissen - en afwijkingen
slaapstoornissen - en afwijkingen
depression
anxiety
sleeping problems
10002861

Registration Number: NL-OMON41276

Lead Sponsor: Ministerie van Volkshuisvesting, Ruimtelijke Ordening en Milieu (VROM)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 272

Inclusion Criteria

Patients: chronic use of ICADTS class III medication (> 6 months)
- age between 21 and 75 (inclusive)
- BMI between 19 an 29 m2/kg (inclusive)
- in posession of a valid drivers license for at least 3 years
- driving experience of at least 3000 km/yeat on average
- sufficient vision

Exclusion Criteria

- a neurological disorder
- use of drugs
- excessive alcohol consumption (> 21 glasses of alcohol/week)
- smoking (> 10 cigarettes/day)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure in this study is the Standard Deviation of Lateral<br /><br>Position (SDLP; in cm)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcome measures will be the results on the following cognitive<br /><br>tests:<br /><br>- Trailmaking A and B<br /><br>- Digit Symbol Substitution Test<br /><br>- Adaptive Tachistoscopic Traffic Perception Test<br /><br>- Reaction Time<br /><br>- Determination Test<br /><br>- Vienna Risk-Taking Test Traffic<br /><br>- Psychomotor Vigilance Task<br /><br>- Driving simulator tests (Swingdrive; Intersections; Merging; Vigilance-SDLP)</p><br>